Skip to content Skip to footer
Subscribe Now
NEWS

Johnson & Johnson Receives the US FDA’s Approval for Darzalex FASPRO Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: The US FDA has approved Darzalex FASPRO (daratumumab and hyaluronidase-fihj) + bortezomib, lenalidomide & dexamethasone (D-VRd) for adults with NDMM who are ineligible for autologous stem cell transplant. Approval was based on the P-III (CEPHEUS) trial, assessing D-VRd vs VRd in 395 ASCT-ineligible or deferred patients across 13 countries in the EU, North America,…
January 28, 2026

Read more

NEWS

Cytokinetics Launches Myqorzo in the US for Obstructive Hypertrophic Cardiomyopathy

Shots: The US FDA approved Myqorzo (aficamten) is now commercially available in the US for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms Myqorzo is a QD, oral cardiac myosin inhibitor available in 5, 10, 15, and 20 mg tablets and directly targets hypercontractility and LVOT obstruction…
January 28, 2026

Read more

ABANZA
NEWS

ABANZA Secures US FDA 510(k) Clearance for QuadLock Fixation System for ACL Reconstruction

Shots: The US FDA has granted 510(k) clearance to ABANZA’s QuadLock Fixation System, a knotless, bidirectional, tension-adjustable device for anterior cruciate ligament (ACL) reconstruction In biomechanical testing under high-demand cyclic loading, QuadLock demonstrated <0.5 mm cyclic displacement representing a >500% reduction in cyclic displacement and >1,000 N pullout strength vs conventional fixation methods QuadLock is…
January 28, 2026

Read more

NEWS

Novaliq Receives US FDA IND Clearance to Advance NOV05 into P-II Trial for Non-infectious Anterior Uveitis

Shots: The US FDA has cleared Novaliq’s IND application for NOV05, enabling initiation of the EYETAC P-II clinical study in pts with non-infectious anterior uveitis (NIAU) The EYETAC P-II study will be conducted in the US and is expected to begin in Q1’26, evaluating the safety, tolerability, and dose-dependent anti-inflammatory effects of NOV05 NOV05 is…
January 27, 2026

Read more

NEWS

BlueOcean Global Receives US FDA 510(k) Clearance for Excelsior External Fixation System

Shots: The US FDA has granted 510(k) clearance to BlueOcean Global’s Excelsior External Fixation System, a circular external fixation platform designed to support both bone reconstruction and soft tissue management The system is cleared for commercial distribution in the US and will be rolled out initially through select centers, with broader availability planned in the…
January 27, 2026

Read more

NEWS

BPGbio’s BPM31510 Receives the US FDA Orphan Drug Designation to Treat Primary CoQ10 Deficiency

Shots: The US FDA has granted ODD to BPM31510, for the treatment of primary coenzyme Q10 (CoQ10) deficiency (PCQD) Designation was supported by insights from BPGbio’s NAi Interrogative Biology platform, which leverages Bayesian AI to analyze & map thousands of human biological data points, validating BPM31510’s therapeutic potential BPM31510 is designed for IV administration of CoQ10 directly…
January 23, 2026

Read more

NEWS

Guardant Health Secures the US FDA Approval for Guardant360 CDx as a Companion Diagnostic for Pfizer’s Braftovi

Shots: The US FDA has approved Guardant360 CDx as a companion diagnostic to identify pts with BRAF V600E-mutant metastatic colorectal cancer who may benefit from treatment with Pfizer’s Braftovi (encorafenib) + cetuximab & CT Accelerated approval was backed by P-III (BREAKWATER) trial assessing encorafenib + cetuximab & CT vs SoC, in which Guardant360 CDx, a non-invasive genomic…
January 23, 2026

Read more

Celcuity
NEWS

The US FDA Accepts Celcuity’s Gedatolisib NDA under Priority Review to Treat HR+/HER2- Breast Cancer

Shots: The US FDA has accepted NDA under priority review of gedatolisib in HR+/ HER2-, PIK3CA wild-type advanced breast cancer, which will be reviewed under RTOR pathway (PDUFA: Jul 17, 2026) NDA was supported by data from the PIK3CA wild-type cohort of the P-III (VIKTORIA-1) study assessing gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2-…
January 22, 2026

Read more

NEWS

SurGenTec Receives the US FDA Clearance for ION-C Facet Fixation System

Shots: The US FDA has granted clearance to ION-C Facet Fixation System, part of SurGenTec’s posterior cervical platform, for the treatment of cervical pseudoarthrosis Clearance was supported by IRB-approved long-term study data showing bridging bone across facet joints with no reported AEs, implant migration, or revision surgeries, & postoperative imaging confirming preserved cervical alignment &…
January 21, 2026

Read more

Load more